Industry resident applies interests in technology and AI to develop proof-of-concept regulatory affairs tool

Pharmaceutical Industry Residency Program Award recipient Romina Sardari with Associate Professor, Teaching Stream, Monica Gautam.

Romina Sardari’s pharmaceutical industry residency project gave her the opportunity to use her interests in technology and artificial intelligence (AI) to develop a tool to aid with a key challenge in global regulatory affairs. Sardari recently received the Pharmaceutical Industry Residency Program Award for her project and is helping adapt her tool for broader use within her department.

“This residency project is very close to my heart. It shows how AI and large language models are becoming very important in the work that we do,” says Sardari. “More pharmacists are stepping into the world of technology and AI. As pharmacists, we can be the bridge between the technical side and the clinical and scientific sides of the work we do, and that puts us in a unique position in the industry.”

“More pharmacists are stepping into the world of technology and AI. As pharmacists, we can be the bridge between the technical side and the clinical and scientific sides of the work we do, and that puts us in a unique position in the industry.”

Sardari started the residency at Hoffmann-La Roche after completing a Doctor of Pharmacy (PharmD) at the University of British Columbia (UBC). She and her sister (also a PharmD student at UBC) started a student group at UBC to give students more exposure to the pharmaceutical industry and health technology fields through networking events and invited speakers. She heard about the residency program at the Leslie Dan Faculty of Pharmacy through the speaker series and decided to apply.

“Before the residency, I had spent my whole life in academia. My studies had been very focused on the clinical side of pharmacy, and while we touched on industry, this field was very unfamiliar to me,” she says. “I saw the residency as a new door to open and an opportunity to explore, so I thought it was worth a try.”

Sardari completed a two-year residency with Hoffmann-La Roche’s Global Regulatory Affairs department, which manages the strategies and interactions with health authorities around the world, including the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in the European Union.

Her residency included rotations with teams in several different subfunctions, which allowed her to gain experience with the different functions of the larger department, including program management, content strategy, and innovation and sustainment.

She says that working in industry presented a steep learning curve, but she enjoyed the challenge and opportunity to apply her skills in a new environment.

“In pharmacy school, we learned so much from clinical skills to pharmacokinetics, data science, and statistics,” she says. “In regulatory affairs, you have to have a little bit of understanding of all these areas, so I could bring all of that knowledge into my role. That was really exciting, and it helped me understand the full value of my education.”

Resident-developed dashboard being adapted to broader use in regulatory affairs

Regulatory affairs relies heavily on precedent and previous regulatory strategies and health authority interactions, and regulatory intelligence professionals may spend many hours searching through internal and external documents, synthesizing information and maintaining intelligence dashboards to inform strategies and decision-making. For Sardari’s award-winning residency project, she developed an automated dashboard that uses AI to search through and summarize information on therapeutic molecules from internal documents and external health agency reports, automatically creating and updating dashboards, saving hours of work and allowing dashboards for more molecules to be created.

“I'm very passionate about technology and data science and AI, and I was able to bring my passion into the work to explore these areas and to have an impact on the company,” says Sardari. “I had always pursued these interests on the side, but through this residency program, I got to bring those skills into my work, see the impact, and become even more interested in it, such that I’m now continuing my education in it.”

“I had always pursued these interests on the side, but through this residency program, I got to bring those skills into my work, see the impact, and become even more interested in it, such that I’m now continuing my education in it.”

Following her development of the proof-of-concept dashboard, Sardari had a rotation with the Regulatory Digital Innovation and Data Strategy team, which was also working on regulatory insight dashboards and data products. Sardari’s project is now being incorporated into the data products, and she was able to become involved with the development.

In April, her rotation ended and she began working as a global regulatory program management specialist at Hoffmann-LaRoche while also pursuing a master’s program in data science at the Georgia Institute of Technology.

She says that the residency has opened new doors and highlighted how varied the pharmacy profession can be.

“Residency, and the associated rotations, opened the door for me to explore different opportunities within industry, what I bring to the table, and what I can expect in my career,” she says. “For me, industry is the peak of where I can use all of the knowledge from my pharmacy school education – the clinical and scientific. My PharmD degree helped jump-start my career with the foundational knowledge, and the residency gave me the opportunity to explore realms that I didn’t know I was even interested in.”